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CMC Strategy Forum Japan 2022 Summary Infographic
![System.Collections.Generic.List`1[System.String] Thumbnail](http://www.casss.org/images/default-source/cmc-japan/2022/cmcj2022_120x120_landing.jpg?sfvrsn=20a1f60b_3)
Summary Infographic: CMC Strategy Forum Japan 2022 -
Commercial Biosimilar Drug Substance Technology Transfer: Approval Accelerated by Clinical Manufacturing Site Experience and Close & Effective Communication Between Sponsor & Health Authority
![System.Collections.Generic.List`1[System.String] Thumbnail](http://www.casss.org/images/default-source/cmc-china/cmcc2022_120x120_landing_new.jpg?sfvrsn=24d4d585_3)
Speaker Presentation McQueen Jocelyn Amgen 2022 -
The Path to Success for mRNA Vaccines
![System.Collections.Generic.List`1[System.String] Thumbnail](https://www.casss.org/images/default-source/discussion-groups/dg2022_120x120_landing71a99938-ff9a-43fd-9caa-bae5fa98d957.jpg?sfvrsn=bcd23e45_1)
Speaker Presentation Ulmer Jeffrey TechImmune LLC_Immorna Therapeutics 2022 -
Capping, Poly(A) tail and LNP Analysis for mRNA Vaccine Product Development
Speaker Presentation Zeng Qi GlaxoSmithKline 2022
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Ensuring Quality and Safety of mRNA Vaccines Today & Tomorrow
Speaker Presentation Acharya Sarita USP 2022
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CMC Strategy Forum Japan 2022 Scientific Program
Scientific Program: CMC Strategy Forum Japan 2022
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Targeted Revision of ICH Q1s/Q5C - Opportunities with Science and Risk-Based Approaches
Speaker Presentation Zimmerman Boris Genentech, a Member of the Roche Group 2022
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Industry Perspective on Polysorbate Degradation & Control Strategies for Biopharmaceutical Products - A View of EFPIA Working Group
Speaker Presentation Wuchner Klaus and Bechtold Peters Karoline Janssen 2022
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Viral Safety - Panel Discussion Questions 2022
Viral Safety - Panel Discussion Questions 2022
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Differences in Regulations on Gene Modified Organisms Between japan, Europe, and the United States
Speaker Presentation Tajima Gentaro Pfizer R&D Japan G.K. 2022
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Concept of the ICH-Q5A Second Revision
Speaker Presentation Sakurai Akira PMDA 2022
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Proteinaceous Visible Particle in Liquid Monoclonal Antibody Formulations
Speaker Presentation Saitoh Satoshi Chugai 2022
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Composition of the Application Material on Quality for the MAA of Regenerative Medical Products
Speaker Presentation Nishikawa Atsushi PMDA 2022
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Global Regulatory Considerations for
Allogeneic Cell Therapies
Speaker Presentation Momonoi Yoko Takeda Pharmaceuticals 2022
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China's Regulatory Framework for Biological
Products and the Latest Trend
Speaker Presentation Li Min Center for Drug Evaluation (CDE) 2022
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Regulatory Considerations for Moving from Emergency Use Authorization to Biological License Application for U.S. Products
Speaker Presentation Levis Robin CBER FDA 2022
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Using Stability Prior Knowledge From ‘Like-molecules’ to Determine Shelf-life
Speaker Presentation Lennard Andrew Amgen 2022
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An Industry Perspective on CHO Cell Product Virus Safety
Speaker Presentation Kobayashi Shohei Chugai 2022
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Points to Consider and Challenges in CMC for Regenerative Medical Products
Speaker Presentation Kitada Mitsuo and Hanada Naoyuki Novartis Pharma K.K. 2022
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PMDA Perspective on Visible Particles
in Biopharmaceuticals
Speaker Presentation Kishioka Yasuhiro PMDA 2022
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For 2021 meetings, content will be available for one year after the program. For 2022 and beyond, content will be available for three months.